The patient has left ventricular outflow tract obstruction with hypertrophic obstructive cardiomyopathy

The patient is on optimal medication

The patient is not eligible for/failed/refused alcohol ablation

The patient is not eligible for/failed/refused myectomy

The patient is willing to participate in the study and has signed informed consent

The patient or legally authorized representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved be the appropriate medical ethics committee.

Exclusion Criteria:

Pregnant or nursing patients Female patients of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test

Patient has history of or known impaired renal function (Serum creatinine >2.0 mg/dL or 177 µmol/l) or on dialysis

Patient has a history of bleeding diathesis or coagulopathy or patients in whom anti-platelet and/or anticoagulant therapy is contraindicated

Patient has a known hypersensivity or contraindication to aspirin, both heparin and bivalirudin, clopidogrel and/or contrast sensitivity/allergy that cannot be adequately pre-medicated

Patient has other medical illness not related to the hypertrophic cardiomyopathy (e.g., cancer, known malignancy, or cognitive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the protocol, confound the data interpretation or is associated with limited life expectancy (i.e., less than 1 year)

Subject is enrolled or intended to participate in any concurrent drug and/or device study, which would confound the results of this trial as determined by the investigator, during the course of this clinical study

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.